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WO2020153321A1 - Cathéter de support - Google Patents

Cathéter de support Download PDF

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Publication number
WO2020153321A1
WO2020153321A1 PCT/JP2020/001831 JP2020001831W WO2020153321A1 WO 2020153321 A1 WO2020153321 A1 WO 2020153321A1 JP 2020001831 W JP2020001831 W JP 2020001831W WO 2020153321 A1 WO2020153321 A1 WO 2020153321A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
outer layer
distal
side portion
end side
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/001831
Other languages
English (en)
Japanese (ja)
Inventor
浩二 亀岡
瑛美 日下部
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nipro Corp
Original Assignee
Nipro Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nipro Corp filed Critical Nipro Corp
Priority to JP2020568145A priority Critical patent/JP7577999B2/ja
Publication of WO2020153321A1 publication Critical patent/WO2020153321A1/fr
Anticipated expiration legal-status Critical
Priority to JP2024091332A priority patent/JP2024109987A/ja
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • the present invention relates to a rapid exchange type support catheter used together with a therapeutic catheter and a guiding catheter to guide the therapeutic catheter to a treatment site.
  • a support catheter may be used together with a therapeutic catheter and a guiding catheter, and as the support catheter, for example, a catheter as disclosed in Patent Document 1 is known.
  • the support catheter of Patent Document 1 has a distal shaft (described as a tubular body in the document) and a proximal shaft (described as a wire in the document).
  • the distal shaft and the proximal shaft are connected in a state where the distal end portion of the proximal shaft and the proximal end portion of the distal shaft partially overlap with each other along the longitudinal direction.
  • the distal shaft and the proximal shaft are connected by covering the outer circumference of the overlapping portion of both with a reinforcing tube.
  • the diameter of the entire support catheter is configured to be smaller than the conventional diameter without reducing the inner diameter of the distal shaft, and the strength at the connecting portion between the distal shaft and the proximal shaft can be further improved.
  • the purpose is to provide a support catheter.
  • the support catheter according to the first aspect is used together with a therapeutic catheter for treating a treatment site and a guiding catheter into which the therapeutic catheter is inserted and which guides the therapeutic catheter in a blood vessel.
  • a support catheter that has a length that is inserted from the proximal opening of the guiding catheter and projects from the distal opening of the guiding catheter, and that guides the distal end of the therapeutic catheter to the treatment site.
  • a distal shaft that is formed into a tubular shape into which the treatment catheter can be inserted and that includes an inner layer, a reinforcing layer, and an outer layer, and a distal end portion is disposed inside the outer layer of the distal shaft.
  • the proximal shaft described above is provided, and the front end side portion of the proximal shaft is formed wider than the remaining portion.
  • the distal end side portion of the proximal shaft is arranged inside the outer layer of the distal shaft, the outermost diameter of the support catheter (which is orthogonal to the axial direction) can be achieved without reducing the inner diameter of the distal shaft.
  • the length in the direction) can be made smaller than in the past.
  • the distal end side portion of the proximal shaft is formed wide, the contact area between the distal end side portion and the distal shaft can be increased. As a result, the strength of the fixed portion increases, and the distal end side portion of the proximal shaft becomes difficult to come off from the distal shaft.
  • a second aspect is the support catheter according to the first aspect, wherein the reinforcing layer of the distal shaft comprises a plurality of metal wires formed in a tubular mesh shape, The tip side portion is fixed to at least one metal wire of the plurality of metal wires.
  • the distal end portion of the proximal shaft is formed wide, the distal end portion can be easily fixed to a thin wire such as a metal wire.
  • 3rd aspect is a support catheter which concerns on a 1st aspect, Comprising:
  • the said tip side part of the said proximal shaft is formed in the annular shape with which the axial direction is arrange
  • the contact area with the distal shaft can be made wider.
  • the 4th aspect is a support catheter which concerns on a 1st aspect, Comprising: The axial direction of the said front end side part of the said proximal shaft is arrange
  • the tip end side portion of the proximal shaft is formed in a C ring shape, the contact area with the distal shaft can be made wider.
  • a fifth aspect is the support catheter according to the first aspect, wherein the distal end side portion of the proximal shaft includes a contrast marker.
  • a sixth aspect is the support catheter according to the first aspect, wherein the metal wire and the proximal shaft are made of stainless steel.
  • a seventh aspect is the support catheter according to the first aspect, wherein the distal end side portion of the proximal shaft is sandwiched between the inner layer and the outer layer of the distal shaft.
  • connection strength can be improved by sandwiching the distal end side portion of the proximal shaft between the inner layer and the outer layer of the distal shaft.
  • An eighth aspect is the support catheter according to the first aspect, wherein the outer layer of the distal shaft is a first configuration outer layer and a second configuration that are arranged adjacent to each other along the axial direction of the distal shaft.
  • the outer layer is composed of two or more constituent outer layers
  • the physical properties such as flexibility of the distal shaft are gradually changed in the axial direction by changing the raw material of each constituent outer layer. be able to.
  • the tip side portion of the proxy shaft is included in the first constituent outer layer by the inclusion of the tip side portion of the proxy shaft in the first constituent outer layer. Is difficult to remove.
  • a ninth aspect is the support catheter according to the first aspect, wherein the second constituent outer layer has a hardness higher than that of the first constituent outer layer.
  • connection between the metal wire and the distal end side portion of the proximal shaft can be made stronger, and the distal end side flexibility of the distal shaft can be ensured. It can be pushed smoothly. Further, since the hardness can be changed stepwise from the base end side portion of the distal shaft to the tip end side portion, it is possible to avoid a kink due to a rapid change in hardness.
  • the diameter of the entire support catheter can be made smaller than before without reducing the inner diameter of the distal shaft, and the strength at the connecting portion between the distal shaft and the proximal shaft can be further improved. It is possible to provide various support catheters.
  • FIG. 1st Embodiment It is a figure showing the state where the support catheter concerning one embodiment of the present invention is used with a medical treatment catheter and a guiding catheter. It is a side view which shows the support catheter of FIG. (A) And (b) is a figure which shows the manufacturing process of the support catheter of 1st Embodiment. It is a top view which shows the front end side part of the proximal shaft of the support catheter of 1st Embodiment. (A) And (b) is a figure which shows the manufacturing process of the support catheter of 2nd Embodiment. (A) And (b) is a figure which shows the manufacturing process of the support catheter of 3rd Embodiment.
  • (A), (b) and (c) is a figure which shows the manufacturing process of the support catheter of 4th Embodiment. It is a figure which shows the modification of the support catheter of 4th Embodiment.
  • (A) is a side view which shows the structure of the metal mold
  • (b) shows the proximal shaft formed by the metal mold
  • PCI Percutaneous coronary intervention
  • the guiding catheter 4, the balloon catheter 5, the support catheter 1, and the guide wire 25 are mainly used.
  • each member used in PCI will be described.
  • the guiding catheter 4 is a catheter for guiding the balloon catheter 5 and the support catheter 1 in the blood vessel, and is inserted into, for example, a radial artery 8 or a femoral artery (not shown) using a sheath 7 described later.
  • the guiding catheter 4 has a guiding catheter body 11 and a Y-shaped connector 12.
  • the guiding catheter main body 11 has a long tube shape, and is configured so that the balloon catheter 5 and the support catheter 1 can be inserted into the guiding catheter main body 11. Further, the guiding catheter main body 11 is made of a bendable cylindrical flexible tube and can be pushed forward in a curved blood vessel.
  • the Y-type connector 12 is provided at the proximal end of the guiding catheter body 11.
  • the Y-type connector 12 has a main body portion 12a and a side arm 12b, and a drug solution or a contrast agent can be injected from the side arm 12b. Further, the tip portion of the body portion 12 a is attached to the base end portion of the guiding catheter body 11.
  • the main body portion 12a has a proximal end side opening 12c, and the balloon catheter 5 and the support catheter 1 can be inserted through the proximal end side opening 12c.
  • the balloon catheter 5 is a therapeutic catheter.
  • the balloon catheter 5 is a catheter that is inserted into the narrowed portion 3 in the coronary artery and pushes and expands the narrowed portion 3.
  • a conventionally known balloon catheter can be appropriately adopted.
  • the balloon catheter 5 is a rapid exchange type (RX type) catheter, and has a treatment catheter body 21 and a connector 22 as shown in FIG.
  • the treatment catheter body 21 is formed in a long tube shape.
  • the treatment catheter main body 21 has a balloon 23 having a stent 24 on its distal end.
  • the stent 24 a conventionally known one can be appropriately adopted.
  • the balloon catheter 5 is used together with the guide wire 25, the guiding catheter 4 and the support catheter 1.
  • the support catheter 1 is a catheter that is advanced from the entrance of the coronary artery 2 to a position closer to the stenosis 3 and guides the balloon 23 of the balloon catheter 5 to the stenosis 3.
  • the support catheter 1 is also a catheter for supporting the balloon 23 when inserting the balloon 23 into the stenosis 3.
  • the support catheter 1 has a length that is inserted from the proximal end side opening 4 b of the guiding catheter 4 and projects from the distal end side opening 4 a of the guiding catheter 4.
  • the support catheter 1 includes a protection member 32, a distal shaft 33, and a proximal shaft 34.
  • the distal shaft 33 is formed in a substantially cylindrical shape, and is configured so that the balloon catheter 5 can be inserted therein.
  • the distal shaft 33 constitutes the distal end side portion 1 a of the support catheter 1.
  • the distal shaft 33 is a generally cylindrical member having a three-layer structure including an inner layer 35, a reinforcing layer 36, and an outer layer including a first outer layer 37 and a second outer layer 38 in this order from the inside.
  • the inner layer 35 of the distal shaft 33 is formed of, for example, polytetrafluoroethylene (PTFE) or tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA).
  • PTFE polytetrafluoroethylene
  • PFA tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer
  • the reinforcing layer 36 of the distal shaft 33 is formed by forming a plurality of metal wires (element wires) 36a made of, for example, stainless steel in a tubular mesh shape, and includes an inner layer 35, a first configuration outer layer 37, and a second configuration. It is arranged between the outer layer 38 and the outer layer 38.
  • element wires element wires
  • 16 metal wires 36a are used to form the reinforcing layer 36.
  • the reinforcing layer 36 can be formed.
  • the reinforcement layer 36 is formed such that the base end side portion of the reinforcement layer 36 projects (exposes) from the base end side portion of the first outer component layer 37.
  • the number of wound metal wires 36a is not limited to eight in each direction.
  • the method of winding the metal wire 36a is not limited to the spiral shape, and a conventionally known method can be adopted.
  • the first constituent outer layer 37 and the second constituent outer layer 38 correspond to the outer layers of the distal shaft 33 (the same applies to each embodiment described later). That is, the outer layer of the distal shaft 33 is composed of the first outer layer 37 and the second outer layer 38.
  • the base end side portion of the second outer layer 38 may be formed in an obliquely cut shape, an arc shape, or a half-moon shape. In this case, the base end side portion of the inner layer 35 is also formed in the same shape. This facilitates insertion of the balloon catheter 5 into the distal shaft 33.
  • the proximal end portion composed of only the inner layer 35 and the second outer layer 38 is formed, and the thickness of the proximal end portion of the distal shaft 33 is reduced, it is easy to insert the balloon catheter 5 into the distal shaft 33.
  • the outer diameter can be reduced. Although the number of outer layers is two, the number is not limited to this and may be three or more.
  • the first outer layer 37 of the distal shaft 33 is made of, for example, a nylon elastomer resin.
  • the hardness of the first component outer layer 37 is lower than the hardness of the second component outer layer 38 described later.
  • the second constituent outer layer 38 of the distal shaft 33 is arranged in contact with the first constituent outer layer 37 along the axial direction of the distal shaft 33, and is formed into a substantially cylindrical shape.
  • the second outer layer 38 is for fixing the tip side portion of the proximal shaft 34 to a portion inside the first outer layer 37 of the distal shaft 33 by a method described later, and then covering the fixed portion.
  • the second outer layer 38 is formed of, for example, polybutylene terephthalate or the like.
  • the hardness of the second component outer layer 38 is higher than the hardness of the first component outer layer 37.
  • the inner layer 35 and the first outer layer 37 may be made of the same material, and are not limited to the above materials.
  • the inner layer 35 and the second outer layer 38 may be made of the same material, and are not limited to the above materials.
  • the outer peripheral surfaces of the first outer layer 37 and the second outer layer 38 may be coated with a hydrophilic polymer containing polyurethane, polyvinylpyrrolidone (PVP) or the like.
  • a tip 39 is integrally provided at the tip of the distal shaft 33.
  • the tip 39 is made of, for example, a polyamide elastomer mixed with bismuth oxide, which is a contrast agent, and has a substantially cylindrical shape.
  • the distal tip 39 is radiopaque so that a shadow appears under fluoroscopy.
  • the proximal shaft 34 is a long wire made of, for example, stainless steel.
  • the surface of the proxy shaft 34 is coated with, for example, PTFE.
  • Protective member 32 is provided at the proximal end of proximal shaft 34.
  • the protection member 32 is a columnar member made of polyamide elastomer or the like.
  • the proximal shaft 34 constitutes the proximal end portion 1b of the support catheter 1. Further, as shown in FIG. 4, the distal end side portion 34a of the proximal shaft 34 is formed wider than the remaining portion.
  • the tip side portion 34a is formed in a flat plate shape by pressing and crushing the tip portion of the proxy shaft 34, which is a wire rod, or shaving.
  • the width (the length in the direction orthogonal to the axial direction) of the distal end side portion 34a of the proximal shaft 34 is preferably, for example, 8% or more of the circumferential length of the distal shaft 33.
  • the thickness of the tip side portion 34a is preferably equal to or smaller than the diameter of the wire rod of the proximal shaft 33.
  • the distal end side portion 34a of the proximal shaft 34 is fixed to a portion inside the first constituent outer layer 37 of the distal shaft 33.
  • a method of fixing the distal end side portion 34a of the proximal shaft 34 to the distal shaft 33 will be described in detail.
  • the base end side portion of the reinforcing layer 36 protrudes from the base end side portion of the first constituent outer layer 37, and the base end side portion of the inner layer 35 is. It is in a state of protruding from the base end side portion of the reinforcing layer 36. That is, the base end side portion of the inner layer 35 projects from the base end side portion of the first component outer layer 37.
  • the distal end side portion 34a of the proximal shaft 34 is fixed to the at least one metal wire 36a protruding from the proximal end side portion of the first outer layer 37 by welding. The welded portion is shown by w1.
  • the distal end side portion 34a of the proximal shaft 34 is arranged between the inner layer 35 and the first outer layer 37 of the distal shaft 33 as viewed in the axial direction. That is, the distal end side portion 34 a of the proximal shaft 34 is fixed to the inner portion of the distal shaft 33 with respect to the first constituent outer layer 37. In this case, the distal side portion 34 a of the proximal shaft 34 is arranged so that the width direction thereof matches the circumferential direction of the distal shaft 33.
  • FIG. 3A a state in which one end of one metal wire 36 a forming the reinforcing layer 36 and the distal end side portion 34 a of the proximal shaft 34 are connected by welding is shown. Each end of the plurality of metal wires 36a forming 36 may be welded to the tip side portion 34a of the proximal shaft 34.
  • the second outer layer 38 is provided so as to cover the distal end side portion 34 a of the proximal shaft 34 and the welded portion w 1 of the metal wire 36 a of the reinforcing layer 36.
  • the tip side portion 34a including the welded portion w1 of the proximal shaft 34 is arranged in the inner cavity of the second constituent outer layer 38
  • the inner circumferential surface of the second constituent outer layer 38 and the outer circumferential surface of the inner layer 35 are And the end surface of the first outer layer 37 and the end surface of the second outer layer 38 are welded together.
  • the support catheter 1 is completed by such a method.
  • the distal end side portion 34a of the proximal shaft 34 and the distal shaft 33 are arranged to overlap in the radial direction, but in this case, the distal end side portion 34a of the proximal shaft 34 is It is desirable that the distal shaft 33 be overlapped by a distance (overlap distance) of 5 to 25% of the entire length of the distal shaft 33. If the overlap distance is shorter than the above range, it is not expected that the connection strength of the distal end side portion 34a with respect to the distal shaft 33 will be sufficiently improved, and if the overlap distance is longer than the above range, the overlap portion becomes hard and the passage property is improved. Can occur.
  • the overlap portion having a substantially elliptical radial cross section is further increased in the axial direction, so that the occupancy rate of the lumen of the distal shaft 33 in the guiding catheter 4 is further increased. I will end up. Therefore, the passage resistance of the distal shaft 33 may increase when performing a procedure using the thinner guiding catheter 4. Furthermore, the insertion resistance of the guide wires may increase when performing a procedure using two guide wires. Therefore, it is desirable that the overlap distance be within the above range.
  • the support catheter 1, guiding catheter 4, balloon catheter 5 and guide wire 25 are used.
  • the practitioner first punctures the radial artery 8 with a needle (not shown), and inserts the sheath 7 into the punctured portion. After that, when the guiding catheter 4 is inserted into the radial artery 8 through the sheath 7, the guiding catheter 4 is pushed until the distal end side opening 4 a thereof passes through the aortic arch 9 and reaches the entrance 2 a of the coronary artery 2, When the side opening 4a reaches the inlet 2a, the guide wire 25 is inserted and the support catheter 1 is inserted from the proximal end side opening 4b of the guiding catheter 4.
  • the support catheter 1 is pushed and pulled by the practitioner, and is pushed forward in the guiding catheter 4 while being guided by the guide wire 25 until the distal end side portion 1a thereof projects from the distal end side opening 4a. As a result, the distal portion 1a of the support catheter 1 is inserted into the coronary artery 2 and further reaches the stenosis 3.
  • the balloon catheter 5 After pushing the distal end side portion 1a of the support catheter 1 to the narrowed portion 3 in this manner, the balloon catheter 5 is subsequently inserted from the proximal end side opening portion 4b of the guiding catheter 4.
  • the balloon catheter 5 has its tip inserted into the distal shaft 33, and is then pushed until it projects from the tip of the distal shaft 33.
  • the distal end portion of the balloon catheter 5 is inserted into the stenosis portion 3, and the balloon 23 and the stent 24 are positioned in the stenosis portion 3. Then, pushing of the balloon catheter 5 is stopped.
  • the tip portion of the balloon catheter 5 is guided to the entrance 2a of the coronary artery 2 by the guiding catheter 4, and further to the narrowed portion 3 by the support catheter 1 at the tip of the entrance 2a. Further, since the distal shaft 33 of the support catheter 1 extends to the stenosis 3 or the vicinity thereof, the distal end of the balloon shaft 5 is pushed by the distal end of the distal shaft 33 when the distal end of the balloon catheter 5 is pushed into the stenosis 3. Is supported. Then, the balloon 23 is inflated by the pressure fluid. At the same time, the stent 24 is expanded and expanded to expand the stenosis 3. Thereby, the blood flow in the narrowed portion 3 can be restored.
  • the distal end side portion 34a of the proximal shaft 34 is welded to the metal wire 36a of the reinforcing layer 36.
  • the distal end side portion 34a of the proximal shaft 34 is fixed between the inner layer 35 of the distal shaft 33 and the first outer layer 37. That is, the distal end side portion 34 a of the proximal shaft 34 is fixed to the inner portion of the distal shaft 33 with respect to the first constituent outer layer 37.
  • the outermost diameter (the length in the direction orthogonal to the axial direction) of the support catheter 1 can be made smaller than before without reducing the inner diameter of the distal shaft 33.
  • the distal end side portion 34a of the proximal shaft 34 is formed wide, the distal end side portion 34a can be welded to the metal wire 36a of the reinforcing layer 36 with a wide contact area. This increases the connection strength of the welded portion w1 and makes it difficult for the tip end side portion 34a of the proximal shaft 34 to come off from the metal wire 36a. That is, it becomes difficult for the distal end side portion 34 a of the proximal shaft 34 to come off the distal shaft 33.
  • the tip side portion 34a of the proxy shaft 34 made of stainless steel is welded and fixed to the metal wire 36a also made of stainless steel. This facilitates the welding of the tip side portion 34a and the metal wire 36a and also improves the welding strength.
  • the second constituent outer layer 38 includes the tip side portion 34a including the welded portion w1 of the proximal shaft 34 and is higher in hardness than the first constituent outer layer 37.
  • This makes it possible to strengthen the connection between the distal end side portion 34a of the proximal shaft 34 including the welded portion w1 and the metal wire 36a, and to secure the flexibility of the distal end side of the distal shaft 33.
  • the support catheter 1 can be smoothly pushed through the guiding catheter 4 and the blood vessel. Further, since the hardness can be changed stepwise from the base end side portion of the distal shaft 33 toward the tip end side portion, it is possible to avoid a kink due to a rapid change in hardness.
  • the distal end side portion 34a of the proximal shaft 34 is not exposed from the distal shaft 33, it seems that the connecting portion between the distal shaft and the proximal shaft, which has been conventionally used, is exposed without being covered. Compared with this mode, it is possible to reduce the number of liquid contact members (wetted parts). As a result, the width of the material used for the proximal shaft 34 (tip side portion 34a) is widened, and the width of the connecting method of the tip side portion 34a is widened. For example, it becomes possible to connect the tip end side portion 34a with an adhesive, and even if the material is temporarily modified by the welding in the case of connecting by welding, it is possible to suppress the decrease in safety.
  • first constituent outer layer 37 and the second constituent outer layer 38 are formed of the same material, so that the first constituent outer layer 37 and the second constituent outer layer 38 are easily welded.
  • the distal shaft 33 in the distal shaft 33 according to the second embodiment, at least one metal wire 36a protruding from the base end side portion of the first component outer layer 37 and the winding of the metal wire 36a.
  • the contrast marker 40 formed in, for example, an annular shape (O-ring shape) is welded to at least one metal wire 36a that is wound in the other direction different from the direction and protrudes from the base end side portion of the first component outer layer 37. To be done.
  • the contrast marker 40 is arranged at the proximal end of the inner layer 35 so that the axial direction thereof is parallel to the axial directions of the distal shaft 33 and the proximal shaft 34.
  • the welded portion between the metal wire 36a wound in one direction and the contrast marker 40 (one end surface of the contrast marker 40) is designated as w1, and the metal wire 36a wound in the other direction and the contrast marker 40 (one of the contrast markers 40 The welded portion with the end face) is shown as w2.
  • the contrast marker 40 is made of metal such as stainless steel or platinum.
  • the distal end portion 34c of the proximal shaft 34 is formed in a wide shape like the distal end side portion 34a of the proximal shaft 34 of the first embodiment described above.
  • a combination of the distal end portion 34c of the proximal shaft 34 and the contrast marker 40 forms a distal end side portion 34b of the proximal shaft 34.
  • the distal end portion 34c of the proximal shaft 34 is welded to the contrast marker 40 while being inserted into the contrast marker 40 from the other end surface side of the contrast marker 40 welded to the plurality of metal wires 36a.
  • the tip side portion 34b of the proximal shaft 34 is formed.
  • the welded portion between the contrast marker 40 and the distal end portion 34c of the proximal shaft 34 is shown as w3.
  • only one welding portion w3 of the contrast marker 40 and the tip portion 34c of the proxy shaft 34 is shown, but in the present embodiment, the welding of the contrast marker 40 and the tip portion 34c is performed. There are multiple parts.
  • the distal end portion 34c of the proximal shaft 34 is welded to the contrast marker 40 to form the wide distal end portion 34b of the proximal shaft 34, the distal end portion 34c in the second embodiment is It does not necessarily have to be flat.
  • the tip portion 34c of the proximal shaft 34 is inserted and welded inside the contrast marker 40 welded to the metal wire 36a, but the invention is not limited to this.
  • the tip portion 34c is the outer periphery of the contrast marker 40. It may be arranged on the surface and welded, or an annular portion of the contrast marker 40 may be provided with a hole penetrating in the axial direction, and the tip portion 34c of the proxy shaft 34 may be inserted into the hole and welded.
  • the second outer layer 38 is provided so as to cover the. Specifically, a state in which the distal end side portion 34b of the proximal shaft 34 including the welded portion w3 is arranged in the inner cavity of the second outer constituent layer 38 (both welded portions w1 and w2 are arranged in the inner lumen of the second outer constituent layer 38).
  • the inner peripheral surface of the second outer layer 38 and the outer peripheral surface of the inner layer 35 are welded together, and the end surface of the first outer layer 37 and the end surface of the second outer layer 38 are welded together.
  • the support catheter 1A is completed by such a method.
  • the overlap distance of the distal end portion 34b of the proximal shaft 34 with respect to the distal shaft 33 and the effect thereof are the same as those in the above-described first embodiment.
  • the outermost diameter of the support catheter 1A can be made smaller than before without reducing the inner diameter of the distal shaft 33. It will be possible. Further, since the welded portion of the tip side portion 34b of the proximal shaft 34 is larger than that in the first embodiment, the connection strength of the tip side portion 34b of the proxy shaft 34 can be improved. This makes it more difficult for the distal end side portion 34b of the proximal shaft 34 to separate from the distal shaft 33.
  • the contrast marker 40 by providing the contrast marker 40, it is possible to reveal the shadow of the distal end side portion 34b of the proximal shaft 34 under fluoroscopy. Accordingly, it is possible to easily recognize the passing state of the distal end side portion 34b of the proximal shaft 34 in the guiding catheter 4, or the proximal end of the distal shaft 33 when the therapeutic catheter is inserted into the distal shaft 33. It serves as a mark for the side opening.
  • the effect of not exposing the distal end side portion 34b of the proximal shaft 34 from the distal shaft 33 is similar to that of the first embodiment.
  • the contrast marker 41 is welded.
  • the contrast marker 41 is arranged on the proximal end face of the inner layer 35 so that its axial direction is parallel to the axial directions of the distal shaft 33 and the proximal shaft 34.
  • the welded portion of the metal wire 36a wound in one direction and the contrast marker 41 (one end surface of the contrast marker 41) is designated as w1, and the metal wire 36a wound in the other direction and the contrast marker 41 (one of the contrast marker 41).
  • the welded portion with the end face) is shown as w2.
  • the contrast marker 41 is made of metal such as stainless steel or platinum.
  • the distal end portion 34c of the proximal shaft 34 is formed in a wide shape like the distal end side portion 34a of the proximal shaft 34 of the first embodiment described above.
  • a combination of the tip end portion 34c of the proxy shaft 34 and the contrast marker 41 forms a tip end side portion 34b of the proxy shaft 34.
  • the contrast marker 41 with the tip end 34c of the proximal shaft 34 being inserted (or fitted) into the cutout portion of the contrast marker 41 from the other end surface side of the contrast marker 41 welded to the metal wire 36a. Be welded to.
  • the tip side portion 34b of the proximal shaft 34 is formed.
  • a welded portion between the contrast marker 41 and the tip end portion 34c of the proximal shaft 34 is shown as w4.
  • only two welding parts w4 of the contrast marker 41 and the tip portion 34c of the proxy shaft 34 are shown, but in the present embodiment, the welding of the contrast marker 41 and the tip portion 34c. There are two or more parts.
  • the distal end portion 34c of the proximal shaft 34 is welded to the contrast marker 41 to form the wide distal end portion 34b of the proximal shaft 34. It does not necessarily have to be flat. Further, the distal end portion 34c of the proxy shaft 34 is inserted (or fitted) into the cutout portion of the contrast marker 41 welded to the metal wire 36a and welded, but the present invention is not limited to this, and the proxy shaft is not limited thereto. It is also possible to weld the tip end portion 34c of 34 and the contrast marker 41 to form the tip end side portion 34b of the proximal shaft 34, and then weld the tip end side portion 34b and the metal wire 36a.
  • the second outer layer 38 is provided so as to cover the. Specifically, a state in which the distal end side portion 34b of the proximal shaft 34 including the welded portion w4 is arranged in the inner cavity of the second constituent outer layer 38 (both welded portions w1 and w2 are arranged in the inner lumen of the second constituent outer layer 38).
  • the inner peripheral surface of the second outer layer 38 and the outer peripheral surface of the inner layer 35 are welded together, and the end surface of the first outer layer 37 and the end surface of the second outer layer 38 are welded together.
  • the support catheter 1B is completed by such a method.
  • the overlap distance of the distal end portion 34b of the proximal shaft 34 with respect to the distal shaft 33 and the effect thereof are the same as those in the above-described first embodiment.
  • the outermost diameter of the support catheter 1B can be made smaller than before without reducing the inner diameter of the distal shaft 33, as in the first embodiment. It will be possible. Further, since the welded portion of the tip side portion 34b of the proximal shaft 34 is larger than that in the first embodiment, the connection strength of the tip side portion 34b of the proxy shaft 34 can be improved. This makes it more difficult for the distal end side portion 34b of the proximal shaft 34 to separate from the distal shaft 33.
  • the welding length between the contrast marker 41 and the distal end portion 34c of the proximal shaft 34 is welded. Can be made longer and welding can be performed via the two opposing surfaces in the cutout portion of the contrast marker 41, and the connection strength between the contrast marker 41 and the distal end portion 34c of the proximal shaft 34 is improved. Further, since the tip end portion 34c of the proximal shaft 34 may be arranged and welded in accordance with the cutout portion of the contrast marker 41, the positioning of the proximal shaft 34 becomes easy.
  • the contrast marker 41 by providing the contrast marker 41, it is possible to reveal the shadow of the distal end side portion 34b of the proximal shaft 34 under fluoroscopy. Accordingly, it is possible to easily recognize the passing state of the distal end side portion 34b of the proximal shaft 34 in the guiding catheter 4, or the proximal end of the distal shaft 33 when the therapeutic catheter is inserted into the distal shaft 33. It serves as a mark for the side opening.
  • the effect of not exposing the distal end side portion 34b of the proximal shaft 34 from the distal shaft 33 is similar to that of the first embodiment.
  • the inner layer 35 is formed, for example, by applying PTFE to the outer surface of the silver-plated copper wire 50.
  • the inner layer 35 is formed so that the base end side portion and the tip end side portion of the inner layer 35 respectively project (expose) from the base end side portion and the tip end side portion of the reinforcing layer 36.
  • the reinforcing layer 36 is provided in a predetermined region in the axial direction of the inner layer 36 by the same method as in the above-described first embodiment.
  • a region where the distal end side portion of the inner layer 35 is covered with the cylindrical distal end tip 39 and the reinforcing layer 36 is provided is covered with the first outer component layer 37.
  • the tip side portion 34a of the proxy shaft 34 is sandwiched between the inner peripheral surface of the second constituent outer layer 38 and the outer peripheral surface of the inner layer 35, the tip side portion of the second constituent outer layer 38 and the first constituent outer layer 37 are formed. Welding with the base end side portion (welding with end face matching) and welding of the inner peripheral surface of the second constituent outer layer 38 and the outer peripheral surface of the inner layer 35 are performed.
  • the tip end side portion 34a of the proximal shaft 34 is fixed between the inner layer 35 of the distal shaft 33 and the second outer layer 38. That is, the distal end side portion 34a of the proximal shaft 34 is fixed to the inner portion of the distal shaft 33 with respect to the second constituent outer layer 38. 7B, the tip side portion 34a of the proximal shaft 34 is retained in the second constituent outer layer 38, but the invention is not limited to this, and the tip side portion 34a is fixed to the first constituent outer layer 37. It may be extended inward, or the distal end side portion 34 a thus extended may be folded into the reinforcing layer 36.
  • the tip end side portion 34a can be present in the entire axial region of the second outer structural layer 38 in the second outer structural layer 38, the strength in the entire axial region of the second outer structural layer 38 can be increased. It is possible to improve.
  • an adhesive may be applied to the tip side portion 34a of the proximal shaft 34, and then the tip side portion 34a may be sandwiched between the inner peripheral surface of the second constituent outer layer 38 and the outer peripheral surface of the inner layer 35.
  • the copper wire 50 is stretched and pulled out.
  • the support catheter 1C is completed by such a method.
  • the overlap distance of the distal end portion 34a of the proximal shaft 34 with respect to the distal shaft 33 and the effect thereof are the same as those in the above-described first embodiment.
  • the outermost diameter of the support catheter 1C can be made smaller than before without reducing the inner diameter of the distal shaft 33. It will be possible. Moreover, since the end surface of the distal end side portion of the second constituent outer layer 38 and the end surface of the base end side portion of the first constituent outer layer 37 are joined and welded, the outer diameter does not increase during welding.
  • the distal end side portion 34a of the proximal shaft 34 is formed in a wide shape, so that the distal end side portion 34a has a large area and the inner layer 35 and the first layer.
  • the welding can be performed in a state of being in contact with the two-component outer layer 38. This makes it difficult for the distal end side portion 34a of the proximal shaft 34 to come off from the distal shaft 33.
  • the tip end side portion 34a of the proximal shaft 34 is sandwiched between the inner layer 35 of the distal shaft 33 and the second outer layer 38, the tip end side portion of the proximal shaft 34 with respect to the distal shaft 33.
  • the connection strength of 34a is improved.
  • the distal end side portion 34a of the proximal shaft 34 is not exposed from the distal shaft 33, it seems that the connecting portion between the distal shaft and the proximal shaft, which has been conventionally used, is exposed without being covered. Compared with this mode, it is possible to reduce the number of liquid contact members (wetted parts). As a result, the width of the material used for the proximal shaft 34 (tip side portion 34a) is widened, and the width of the connecting method of the tip side portion 34a is widened. For example, it becomes possible to connect the tip end side portion 34a with an adhesive, and even if the material is temporarily modified by the welding in the case of connecting by welding, it is possible to suppress the decrease in safety.
  • the outer peripheral surface of 35 is welded.
  • the radial cross-section outer shape of the distal shaft 33 is not an elliptical shape but a shape close to a perfect circle. Therefore, when performing a procedure using two guide wires, it becomes easy to pass the second guide wire.
  • distal end side portion 34a and the reinforcing layer 36 do not overlap in the radial direction, it becomes possible to make the wall thickness of the distal shaft constant over the axial direction, and the maximum inner diameter with respect to the constant outer diameter. Can be secured. Further, it is possible to prevent the distal end side portion 34a of the proximal shaft 34 from protruding from the first outer layer 37 and the second outer layer 38 of the distal shaft 33.
  • the tip side portion of the proxy shaft 34 may be formed as follows. As shown in FIG. 9A, an upper mold 110 and a lower mold 112 configured to be capable of reciprocating in the vertical direction are prepared. The inclined portion 111 is fixed to one side (left side in the figure) of the inner surface of the upper die 110, and the inclined portion 113 is fixed to one side (left side in the figure) of the inner side surface of the lower die 112. There is. In the figure, the inclined portion 111 is inclined upward to the right, and the inclined portion 113 is inclined downward to the right.
  • One end of the proxy shaft 34 which is a flat wire, is arranged between the upper mold 110 and the lower mold 112, and the upper mold 110 and the lower mold 112 are moved in the directions in which they approach each other.
  • the proxy shaft 34 is pressed.
  • FIG. 9B it is possible to obtain the proximal shaft 34A including the distal end side portion 34A2 having the triangular (tapered) distal end portion 34A1 in a side view.
  • the tip end portion 34A1 shown in FIG. 9B may be formed horizontally without the inclined portion on the upper side.
  • the inclined portion 111 of the upper mold 110 is removed to make the upper mold 110 a fixed mold.
  • the tip portion 34a1 of the tip side portion 34a of the proxy shaft 34 which is a flat wire, is irradiated with laser (laser irradiation point w10 is, for example, 3 points) to eliminate the corners of the tip portion 34a1. be able to. Accordingly, when the tip portion 34a1 is covered with the outer layer, it is possible to suppress or prevent the tip portion 34A1 from being caught by the outer layer.
  • the laser irradiation point w10 is not limited to three points, and may be less than three points or four points or more.
  • the tip side portion of the proxy shaft may be formed as follows. As shown in FIG. 11, the distal end side portion 34B1 of the proximal shaft 34B can be an arc piece that has an arc shape when viewed in the axial direction. This facilitates contact of the distal end portion 34B1 along the curved surface of the inner layer 35 of the distal shaft 33, facilitating welding of the distal end portion 34B1 and firmly fixing the proximal shaft 34 and the distal shaft 33. become.
  • the tip side portions 34a and 34b of the proximal shaft 34 are formed in a flat plate shape, an O-ring shape, or a C ring shape, but the present invention is not limited to this, and the distal end of the proxy shaft 34 is not limited thereto.
  • the side portions 34a and 34b may be formed wider than the remaining portion and may have a shape that can be arranged between the inner layer 35 and the outer layer.
  • the tip side portion 34a of the proxy shaft 34 and the contrast markers 40 and 41 are fixed to the metal wire 36a by welding, or the tip of the proxy shaft 34 is fixed to the contrast markers 40 and 41.
  • the portion 34c is fixed by welding, it is not limited to this and may be fixed by, for example, an adhesive agent.
  • the distal end side portion 34a of the proximal shaft 34 is configured to be fixed between the inner layer 35 of the distal shaft 33 and the first outer layer 37, but the present invention is not limited to this.
  • the fixing portion of the distal end side portion 34 a of the proximal shaft 34 may be a portion inside the first constituent outer layer 37 of the distal shaft 33.
  • the second constituent outer layer 38 and the first constituent outer layer 37 are formed of the material having the same composition, but the present invention is not limited to this, and the second constituent outer layer 38 and The first outer layer 37 may be made of a material having a different composition. As a result, it becomes possible to gradually change the physical properties such as flexibility of the distal shaft 33 in the axial direction.
  • the distal end side portion 34a of the proximal shaft 34 is configured to be arranged while being retained in the region of the inner peripheral surface of the second constituent outer layer 38, but is not limited to this. As shown in FIG. 8, the distal end side portion 34a of the proximal shaft 34 may be extended to the region of the inner peripheral surface of the first outer layer 37. In this case, the tip side portion 34a of the proximal shaft 34 is not only sandwiched between the inner peripheral surface of the second constituent outer layer 38 and the outer peripheral surface of the inner layer 35, but also the inner peripheral surface of the first constituent outer layer 37 and the inner layer 35.
  • the connection strength of the tip side portion 34a of the proximal shaft 34 is further improved. Further, according to the above configuration, since the flexible portion composed only of the inner layer 35 and the outer layer can be eliminated, it is possible to prevent a kink in the portion.
  • the reinforcing layer 36 may extend to the proximal end portion of the distal shaft 33, and the proximal end portion of the reinforcing layer 36 and the distal end portion 34a of the proximal shaft 34 may be covered with the second outer layer 38. Good. Even in this case, it is possible to avoid a kink due to a sudden change in hardness, and it is possible to adjust the hardness of the distal shaft 33 by the length of the reinforcing layer 36 to be extended.
  • the first component outer layer 37 may be welded before the second component outer layer 38 is welded, but the portion of the first component outer layer 37 excluding the base end side portion is first. It is also possible to weld the base end side portion together with the second outer layer 38 after welding. This is because it is possible to prevent the connecting portions of the first outer layer 37 and the second outer layer 38 from overlapping and becoming thicker, and to prevent a gap between the both, which is separated from each other.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter de support qui est configuré pour que son diamètre soit plus petit que ceux des produits classiques, sans réduire le diamètre interne d'un arbre distal et qui permet d'améliorer encore la résistance d'une partie de liaison entre l'arbre distal et un arbre proximal. Ce cathéter de support est pourvu : d'un arbre distal tubulaire dans lequel un cathéter de traitement médical peut être inséré et qui est formé en incluant une couche interne, une couche de renforcement et une couche externe ; et un arbre proximal ayant la partie latérale d'extrémité avant disposée dans une partie interne par rapport à la couche externe de l'arbre distal. La partie latérale d'extrémité avant de l'arbre proximal est plus large que la partie restante.
PCT/JP2020/001831 2019-01-23 2020-01-21 Cathéter de support Ceased WO2020153321A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2020568145A JP7577999B2 (ja) 2019-01-23 2020-01-21 サポートカテーテル
JP2024091332A JP2024109987A (ja) 2019-01-23 2024-06-05 サポートカテーテル

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019009122 2019-01-23
JP2019-009122 2019-01-23

Publications (1)

Publication Number Publication Date
WO2020153321A1 true WO2020153321A1 (fr) 2020-07-30

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2020/001831 Ceased WO2020153321A1 (fr) 2019-01-23 2020-01-21 Cathéter de support

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JP (2) JP7577999B2 (fr)
WO (1) WO2020153321A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022154118A1 (fr) * 2021-01-18 2022-07-21 テルモ株式会社 Cathéter et ensemble cathéter
JP2023018560A (ja) * 2021-07-27 2023-02-08 ニプロ株式会社 カテーテル、カテーテルの製造方法、及び造影マーカのかしめ方法
WO2024166551A1 (fr) * 2023-02-09 2024-08-15 テルモ株式会社 Dispositif médical et son procédé de fabrication

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012510329A (ja) * 2008-12-03 2012-05-10 アンジオメト・ゲーエムベーハー・ウント・コンパニー・メディツィンテクニク・カーゲー 伸縮自在なカテーテル
JP2016517320A (ja) * 2013-03-15 2016-06-16 キューエックスメディカル リミテッド ライアビリティ カンパニー ブースティングカテーテルおよび関連するシステムおよび方法
WO2018030075A1 (fr) * 2016-08-10 2018-02-15 ニプロ株式会社 Cathéter de support.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012510329A (ja) * 2008-12-03 2012-05-10 アンジオメト・ゲーエムベーハー・ウント・コンパニー・メディツィンテクニク・カーゲー 伸縮自在なカテーテル
JP2016517320A (ja) * 2013-03-15 2016-06-16 キューエックスメディカル リミテッド ライアビリティ カンパニー ブースティングカテーテルおよび関連するシステムおよび方法
WO2018030075A1 (fr) * 2016-08-10 2018-02-15 ニプロ株式会社 Cathéter de support.

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022154118A1 (fr) * 2021-01-18 2022-07-21 テルモ株式会社 Cathéter et ensemble cathéter
JP2023018560A (ja) * 2021-07-27 2023-02-08 ニプロ株式会社 カテーテル、カテーテルの製造方法、及び造影マーカのかしめ方法
JP7746717B2 (ja) 2021-07-27 2025-10-01 ニプロ株式会社 カテーテル、カテーテルの製造方法、及び造影マーカのかしめ方法
WO2024166551A1 (fr) * 2023-02-09 2024-08-15 テルモ株式会社 Dispositif médical et son procédé de fabrication

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JP7577999B2 (ja) 2024-11-06
JPWO2020153321A1 (ja) 2021-12-02

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